Search Results

Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Skin Phototypes I-IV.

Laser Cap is a hand-held cap-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the cap covers the user's scalp to ensure the laser light reaches the user's scalp. Model Hat-01 contains 82 laser diodes.

The provided text is a 510(k) summary for the "Laser Cap, Model: Hat-01" device. It outlines the regulatory clearance process and compares the device to predicate devices. However, it does not contain information about acceptance criteria for a study proving device performance, nor details of such a study.

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics and adherence to safety and electromagnetic compatibility (EMC) standards.

Specifically, the "Performance Data" section (numbered VIII) lists biocompatibility testing and electrical and EMC safety testing. These are general compliance tests for medical devices, not a study designed to prove the efficacy of the "Laser Cap" in promoting hair growth against established acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance: This information is not present.
2. Sample size used for the test set and data provenance: No efficacy study is described.
3. Number of experts used to establish ground truth and qualifications: Not applicable, as no clinical efficacy study is detailed.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study details: No such study is mentioned.
6. Standalone (algorithm-only) performance: This device is a physical laser cap, not an algorithm.
7. Type of ground truth used: Not applicable, as no clinical efficacy study is detailed.
8. Sample size for the training set: Not applicable, as this is a physical device, not an AI/ML model being trained.
9. How ground truth for the training set was established: Not applicable.

The document's purpose is to show that the new device is as safe and effective as existing, cleared devices, primarily through comparison of design, materials, and compliance with general safety standards, rather than presenting a novel clinical efficacy study.

Ask a specific question about this device

LLLT Laser Hair Growth Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.

LLLT Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of visible red light-emitting diodes at 650mm and 5mW each. LLLT Laser Hair Growth Cap includes three models, Hair Care 210, Hair Care 135 and Hair Care 210 (210 diodes) is the typical model, Hair Care 135 (135 diodes) and Hair Care 88 (88 diodes) are exactly the same as the Hair Care 210 regarding structure design, intended use, performance and operation, with the difference being the diode amount. Each model has three colors, which are white, hidden color and pool blue.

This document is a 510(k) Pre-Market Notification from Shenzhen CosBeauty Technology Co., Ltd. to the FDA for their LLLT Laser Hair Growth Cap. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

Absence of Clinical Study for Device Acceptance Criteria

Critically, the provided document does not report any clinical study data or acceptance criteria related to the device's efficacy in promoting hair growth. The submission focuses on demonstrating substantial equivalence to a predicate device (CAPOGEN Laser Cap, K201854) and a reference device (Lasercap Family of Lasers, K203826) primarily through non-clinical testing and comparison of technical specifications.

The provided text explicitly states in section (9) "Non-clinical studies and tests performed" and section (10) "Conclusion" that non-clinical testing was conducted to verify compliance with design specifications and safety standards. There is no mention of a clinical trial, performance study, or any data proving the device meets specific efficacy-related acceptance criteria for hair growth.

Therefore, I cannot provide information on:

• A table of acceptance criteria and the reported device performance: No performance criteria for hair growth are stated, nor is performance data presented.
• Sample size used for the test set and data provenance: No clinical test set is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a clinical test set is mentioned.
• Adjudication method for the test set: No clinical test set is mentioned.
• If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No such study is mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: No ground truth for clinical efficacy is mentioned.
• The sample size for the training set: Not applicable as no AI algorithm or training set for clinical efficacy is mentioned.
• How the ground truth for the training set was established: Not applicable.

What the document does describe are safety and performance standards for the device itself (e.g., electrical safety, biocompatibility, laser classification) and a comparison of its technical specifications to predicate devices to establish substantial equivalence.

The "Acceptance Criteria" for this 510(k) submission are therefore implied to be the successful demonstration of:

1. Substantial Equivalence: The subject device (LLLT Laser Hair Growth Cap) is as safe and effective as a legally marketed predicate device, as determined by technical comparison and non-clinical testing.
2. Compliance with Recognized Standards: The device meets applicable national and international consensus standards for medical electrical equipment, laser safety, and biocompatibility.

Here's what can be extracted regarding the device and its assessment:

Device Acceptance Criteria (Implied for 510(k) Substantial Equivalence and Safety):

Study Information (Non-Clinical):

• Sample Size for Test Set and Data Provenance: Not applicable for clinical efficacy. For non-clinical studies, the "sample size" would refer to the number of devices or components tested. This is not explicitly stated but implied to be sufficient for compliance testing. The provenance is Shenzhen, China (manufacturer location) and third-party labs. All studies are presumably prospective for the purpose of this 510(k) submission.
• Number of Experts and Qualifications: Not applicable for establishing "ground truth" for clinical efficacy. Experts would be involved in designing and conducting the non-clinical tests (e.g., electrical engineers, toxicologists), but their specific number and qualifications are not detailed in this summary.
• Adjudication Method: Not applicable for clinical efficacy. For non-clinical tests, results are typically assessed against pre-defined thresholds or criteria in the respective standards.
• MRMC Comparative Effectiveness Study: Not done.
• Standalone Performance (Algorithm): Not applicable; this is a physical LLLT device, not an AI algorithm.
• Type of Ground Truth: For the non-clinical studies, the "ground truth" refers to the established technical standards (e.g., IEC, ISO) and the measurable properties of the device (e.g., electrical output, laser wavelength, material cytotoxicity).
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

Conclusion:

The K213447 submission is a premarket notification based on demonstrating "substantial equivalence" of the LLLT Laser Hair Growth Cap to an existing legally marketed device. This pathway generally relies on demonstrating that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The "studies" referenced are non-clinical bench tests and comparisons against recognized standards to ensure the device's safety and fundamental performance characteristics are equivalent to the predicate. There is no reported clinical study in this document to prove the device meets specific acceptance criteria for hair growth efficacy itself. The efficacy is implicitly accepted based on the predicate device's prior clearance and the similarity of the technology.

Ask a specific question about this device

ID-500 iRestore Hair Growth System: iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V and in females who have Ludgwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin Types I to IV.

The ID-500 iRestore Hair Growth System are two low-level laser/light systems operating at different wavelengths. The ID-500 iRestore Hair Growth System consists of laser and LED operating at 655 ± 10 nanometers. The physical configuration of the device is that of a helmet containing an inner and outer liner, stabilized with a silicone pad lined fixation ring. The systems operate on line voltage at 100 or 240 volts. The helmet's inner liner permits full adjustment to any head shape by means of non-toxic silicone pad. The helmet contains 5-millwatt-diode lasers and 5-milliwatt, super luminescent diodes, that emit red light.

The provided text describes the ID-500 iRestore Hair Growth System and its substantial equivalence to a predicate device, the iRestore Professional 282. However, it does not include detailed acceptance criteria for a device performance study in terms of clinical outcomes (e.g., hair count increase) or a study proving the device meets those clinical criteria. Instead, the document focuses on non-clinical performance data demonstrating safety and electrical/laser compliance.

Therefore, many of the requested elements for a clinical performance study (like sample size for test sets, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are not available in this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

The document primarily discusses acceptance criteria related to safety and engineering standards, not clinical efficacy.

2. Sample size used for the test set and the data provenance:
This information is not provided as there is no description of a clinical performance study with a test set of human subjects. The "test set" here refers to the samples used in the non-clinical tests (e.g., cytotoxicity tests would use cell cultures or animal models, electrical safety tests would use the device itself). The document does not specify details about these samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there is no mention of a human-centric performance study where experts would establish a ground truth for clinical outcomes like hair growth. The "ground truth" for the non-clinical tests would be defined by the standards themselves (e.g., a cytotoxicity assay result being below a certain threshold).

4. Adjudication method for the test set:
This information is not applicable for the same reasons as above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device described is a low-level laser/light therapy system for hair growth, not an AI-powered diagnostic tool requiring human reader interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is not an algorithm.

7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by the harmonized standards (ISO, ANSI, IEC, ASTM) and FDA guidance documents that the device was tested against. For example:

• Safety standards: Passing specific thresholds for electrical leakage, laser emission limits, or biocompatibility responses.
• Software compliance: Adherence to defined software development and validation practices.
• Lifetime/Transportation: Meeting predefined engineering specifications for durability and package integrity.

8. The sample size for the training set:
This information is not applicable as the device is a hardware product, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.

Summary of the Study:

The document describes a non-clinical performance study focused on demonstrating the safety and engineering compliance of the ID-500 iRestore Hair Growth System. The study involved testing the device against various national and international standards related to biocompatibility, electrical safety, electromagnetic compatibility, home use environment, laser safety, software validation, product lifetime, and transportation durability. The results of these tests confirmed that the device met the design inputs and performance specifications required by these standards, supporting its safety and effectiveness from an engineering and manufacturing perspective, and its substantial equivalence to the predicate device. No clinical efficacy study or AI-related performance study is detailed in this document.

Ask a specific question about this device